U.S. patent application number 10/822697 was filed with the patent office on 2004-12-02 for apparatus for performing diagnostic and therapeutic modalities in the biliary tree.
Invention is credited to Cotton, Peter B., Eddy, Bryan P., Rowland, Christopher A., Vergano, Michael G..
Application Number | 20040243056 10/822697 |
Document ID | / |
Family ID | 26934886 |
Filed Date | 2004-12-02 |
United States Patent
Application |
20040243056 |
Kind Code |
A1 |
Rowland, Christopher A. ; et
al. |
December 2, 2004 |
Apparatus for performing diagnostic and therapeutic modalities in
the biliary tree
Abstract
Catheter apparatus for performing diagnostic and therapeutic
modalities in the biliary tree includes a catheter with multiple
lumens. A first lumen is adapted to receive a guidewire and can
serve as a transport lumen for contrast agent. A second lumen
carries a cutting wire for performing a sphincterotomy. A third
lumen can be used as an inflation lumen for a distally located
balloon. Expansion of the balloon occludes a portion of the biliary
tree and allows the catheter to sweep any gallstones through the
sphincter of Oddi into the duodenum.
Inventors: |
Rowland, Christopher A.;
(Marlborough, MA) ; Vergano, Michael G.;
(Cumberland, RI) ; Eddy, Bryan P.; (Broomfield,
CO) ; Cotton, Peter B.; (Charleston, SC) |
Correspondence
Address: |
Fulbright & Jaworski L.L.P.
Steven M. War
Market Square
801 Pennsylvania Avenue, N.W.
Washington
DC
20004-2623
US
|
Family ID: |
26934886 |
Appl. No.: |
10/822697 |
Filed: |
April 13, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10822697 |
Apr 13, 2004 |
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10219347 |
Aug 16, 2002 |
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6743217 |
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10219347 |
Aug 16, 2002 |
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09541931 |
Apr 3, 2000 |
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6547758 |
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09541931 |
Apr 3, 2000 |
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09356685 |
Jul 20, 1999 |
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6443924 |
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09356685 |
Jul 20, 1999 |
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09154834 |
Sep 17, 1998 |
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09154834 |
Sep 17, 1998 |
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08842210 |
Apr 23, 1997 |
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5868698 |
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08842210 |
Apr 23, 1997 |
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08648356 |
May 14, 1996 |
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5683362 |
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08648356 |
May 14, 1996 |
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08242168 |
May 13, 1994 |
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5547469 |
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Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61B 18/10 20130101;
A61B 2018/144 20130101; A61B 2018/00553 20130101; A61B 17/22032
20130101; A61B 2017/22082 20130101; A61B 17/32056 20130101; A61B
2017/22051 20130101; A61M 2025/004 20130101; A61M 25/0029 20130101;
A61B 18/1492 20130101; A61B 17/320725 20130101; A61M 25/003
20130101; A61B 2018/00642 20130101 |
Class at
Publication: |
604/096.01 |
International
Class: |
A61M 029/00 |
Claims
1-26 (Cancelled)
27. In a catheter comprising a plurality of lumens, a proximal and
a distal end, a proximal and a distal portion, a longitudinal axis
extending from said proximal to said distal end, a handle at said
proximal end, and a cutting device at said distal portion, the
improvement comprising: radially offsetting a lumen of said
plurality of lumens, said lumen containing a wire connecting said
distal cutting device to said handle.
28. The improvement of claim 27 wherein said distal portion may
assume at least a right angle configuration.
29. The improvement of claim 27 wherein said cutting device is a
heated wire.
30. A medical device adaptable for performing a plurality of
medical procedures comprising: a catheter comprising a plurality of
lumens, a proximal and a distal end, a proximal and a distal
portion, a longitudinal axis extending from said proximal end to
said distal end, wherein said catheter diameter decreases from said
proximal end to said distal end; a handle at said proximal end; a
cutting device at said distal portion; and a device for object
removal at said distal end.
31. The medical device of claim 30 wherein said cutting device is a
heated wire.
32. The medical device of claim 30 wherein said device for object
removal is an expansible balloon and said proximal portion
comprises: at least one entry port for inflating said balloon
connected to a lumen of said catheter and wherein said lumen ends
at an exit port in said distal portion for inflating said
balloon.
33. The medical device of claim 32 wherein said entry port includes
a Luer-lock fitting.
34. The medical device of claim 30 wherein said cutting device
comprises a cutting wire and a reinforcing sleeve.
35. The medical device of claim 30 wherein said cutting device
comprises a cutting wire extending exterior to said catheter
between longitudinally spaced skived ports.
36. The medical device of claim 30 wherein each lumen comprises: an
entry port located in said proximal portion of said catheter and an
exit port in said distal portion of said catheter.
37. A method for removing objects from the biliary tree using a
duodenoscope introduced through the alimentary tract comprising:
positioning the distal end of a duodenoscope in a patient's
duodenum adjacent to the sphincter of Oddi; inserting into said
duodenoscope a catheter comprising a plurality of lumens, a
proximal and a distal end, a proximal and a distal portion, a
longitudinal axis extending from said proximal end to said distal
end, a handle at said proximal end, a cutting device at said distal
portion, and a device for object removal at said distal end, and
wherein said catheter diameter decreases from said proximal end to
said distal end; and deploying said device for object removal in
proximity to objects to be removed from the biliary tree.
38. The method of claim 37 wherein said device for object removal
is an expandable balloon and wherein said step of deploying said
device for object removal comprises: deploying said expandable
balloon distally of objects to be removed from the biliary
tree.
39. The method of claim 37 further comprising the step of
positioning the catheter through fluoroscopy.
40. The method of claim 39 wherein said step of positioning the
catheter through fluoroscopy includes the step of: injecting a
contrast agent.
41. The method of claim 40 further including the step of: verifying
the presence of objects to be removed using said contrast
agent.
42. The method of claim 37 further comprising the step of:
enlarging the sphincter of Oddi using said cutting device.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This is a continuation application of our co-pending U.S.
patent application Ser. No. 08/648,356 filed May 14, 1996 for an
Apparatus for Performing Diagnostic and Therapeutic Modalities in
the Biliary Tree that is a continuation of our U.S. patent
application Ser. No. 08/242,168 filed May 13, 1994 for an Apparatus
for Performing Diagnostic and Therapeutic Modalities in the Biliary
Tree now U.S. Pat. No. 5,547,469 issued Aug. 20, 1996.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention generally relates to apparatus that is useful
in performing diagnostic and therapeutic modalities in the biliary
tree and more particularly to apparatus that is adapted for
facilitating the diagnosis of gallstones in the bile duct and other
portions of the biliary tree and the removal of such
gallstones.
[0004] 2. Description of Related Art
[0005] Historically the migration of gallstones into an
individual's common bile duct was corrected by general surgical
procedures. A surgeon would incise the bile duct and remove the
gallstones and normally remove the gallbladder. In recent years
less invasive treatment modalities have replaced these general
surgical procedures and reduced patient trauma, long hospital stays
and recovery periods.
[0006] For example, U.S. Pat. No. 4,696,668 and U.S. Pat. No.
4,781,677, both to Wilcox, disclose a treatment modality involving
the administration of a dissolution agent in the bile duct to
essentially dissolve any gallstones. More specifically, a catheter
contains several lumens for inflating and deflating each of two
balloons, venting bile, and infusing and aspirating the dissolution
agent. Inflating the balloons occludes the bile duct at two spaced
sites and creates a sealed spaced that receives the dissolution
agent. As the space is sealed from the remaining biliary tree, the
dissolution agent finds access to the gallbladder and any
gallstones therein through the cystic duct with the exclusion of
bile from the gallbladder fundus. The dissolution agent also will
be confined in high concentration around bile duct gallstones.
After the gallstones dissolve the balloons are deflated and the
catheter can be withdrawn. In this particular approach, the
catheter is directed into the biliary tree using a standard
duodenoscope that passes through the alimentary tract. Although
this and analogous approaches have the potential of minimizing
patient trauma, such treatments require extended placement of the
duodenoscope in the patient, exhibit low efficacy and introduce a
potential for adverse reactions to the dissolution agents.
[0007] In an alternative-approach, a surgeon directs a surgical
extractor into the biliary tree through at least an incision in the
bile duct. For example, in U.S. Pat. No. 3,108,593 to Glassman a
surgeon incises both the bile duct and duodenum. Then the surgeon
directs an extractor through the bile duct incision, biliary tree,
sphincter of Oddi and duodenum to exit through the duodenum
incision. This extractor includes a series of longitudinally spaced
cages for trapping any gallstones in the bile duct and removing
them through either of the incisions.
[0008] U.S. Pat. No. 4,627,837 to Gonzalo discloses a catheter
device with a pair of inflatable balloons at its distal end. This
catheter is led through an incision in the bile duct toward the
duodenum. After the distal balloon passes through the sphincter of
Oddi, both balloons are expanded to anchor the catheter in place.
This enables the catheter to be used for irrigating and flushing
through other lumens in order to capture any gallstone in the
second balloon for removal through the incised bile duct.
[0009] In accordance with still another modality as for the
treatment of strictures, a surgeon may insert a catheter device
through the bile duct or duodenum for the purpose of dilating or
enlarging the sphincter of Oddi. For example, U.S. Pat. No.
4,705,041 to Kim discloses a dilator that is directed through an
incision in the bile duct and the sphincter of Oddi. An expandable
tip dilates the sphincter of Oddi. U.S. Pat. No. 5,035,696 to
Rydell discloses an electrosurgical instrument that is directed
through the duodenum and to the sphincter of Oddi for performing a
sphincterotomy. This apparatus contains a cutting wire that is
heated to cut the sphincter muscle. U.S. Pat. No. 5,024,617 to
Karpiel, discloses a similar device that can be directed through a
duodenoscope. U.S. Pat. No. 5,152,772 to Sewell, Jr. discloses a
device for performing a sphincterotomy that is directed through an
incision in the bile duct and includes a knife for cutting the
sphincter muscle.
[0010] The use of the duodenoscope and sphincterotomy devices, such
as shown in the Rydell and Karpiel patents, enables an internist to
diagnose and treat problems in the biliary tree with minimal
patient invasion. For example, modalities as described in these
patents eliminates the surgery needed for incising the bile duct.
Consequently, these modalities can be performed as outpatient or
day surgical procedures. These procedures greatly reduce patient
trauma, the length of a hospital stay and recovery times. For
example, if an internist determines that gallstones are present in
the biliary tree, particularly the common bile duct, the internist
can insert a duodenoscope into the duodenum to view the sphincter
of Oddi. Then a first catheter can be advanced through the working
channel of the duodenoscope with or without a guidewire and
directed through the sphincter of Oddi into the biliary tree.
Contrast agent injected through the catheter enables fluoroscopy or
other imaging procedures to confirm the presence of gallstones
within the biliary tree. Next the internist exchanges the first
catheter for a second catheter for performing a sphincterotomy such
as the types disclosed in the above-identified Rydell and Karpiel
patents. The second catheter is then exchanged for a third catheter
such as shown in the Glassman patent or some other equivalent
retrieval catheter for drawings gallstones through the enlarged
sphincter of Oddi. Thereafter the retrieval catheter is manipulated
to release the gallstone into the duodenum. The catheter, any
guidewire and the duodenoscope can then be removed to complete the
procedure.
[0011] This procedure is significantly less traumatic to the
patient than other prior art procedures because the only incision
occurs during the sphincterotomy. However, this procedure as
presently practiced requires three separate catheters and two
catheter exchanges. These exchanges are required because the first,
second and third catheters function solely to inject contrast agent
to perform the sphincterotomy and to dislodge gallstones,
respectively. The time required for performing each catheter
exchange can increase patient trauma and increase the duration of
the procedure and reduce efficiency. Moreover, each such procedure
requires the use of two or three separate catheter devices.
SUMMARY
[0012] Therefore, an object of this invention is to provide
apparatus for performing both diagnosis and additional therapeutic
treatment without requiring a catheter exchange.
[0013] Another object of this invention is to provide apparatus for
performing diagnosis and treatment in the biliary tree that can
reduce patient trauma.
[0014] Yet another object of this invention is to provide apparatus
that enables the removal of gallstones from the biliary tree by a
procedure that reduces the number of required catheters and
catheter exchanges.
[0015] Still another object of this invention is to provide a
single catheter apparatus that can perform a sphincterotomy and
remove gallstones in the common bile duct.
[0016] Yet another object of this invention is to provide a single
catheter apparatus that can perform a sphincterotomy and inject
contrast material into the biliary tree.
[0017] Still yet another object of this invention is to provide a
single catheter apparatus that can inject contrast agent into
biliary tree, performing a sphincterotomy and remove gallstones in
the bile duct into the duodenum.
[0018] In accordance with one aspect of this invention, apparatus
can be used in a treatment modality including an enlargement
procedure and another procedure to be performed. This .apparatus
includes a catheter with proximal and distal ends and proximal and
distal portions. The catheter includes first, second and third
generally parallel lumens. The first lumen has a greater diameter
than either of the second and third lumens and the lumens each
extend between proximal and distal portions of the catheter. The
apparatus for performing the enlargement procedure extends through
the second lumen for operating distally of the catheter in response
to manipulations of an operator at the proximal end of the
catheter. The first lumen has a proximal port for enabling access
to the first lumen and the third lumen has a proximal port and a
distal port for enabling the remote control of some other
procedure.
[0019] In accordance with another aspect of this invention,
apparatus is provided for removing objects from the biliary tree.
This apparatus includes a catheter that is directed through the
working channel of a duodenoscope and the sphincter of Oddi into
the biliary tree. The catheter includes first, second and third
lumens with the first lumen being larger than either the second or
third lumens and the lumens generally extending between proximal
and distal portions of the catheter along parallel axes. Apparatus
for cutting the sphincter of Oddi includes a cutting wire extending
through the second lumen and externally of the catheter
means-through a distal port along a length that is coextensive with
part of the distal portion of the catheter. A handle attaches to
the catheter at the proximal portion and to the proximal wire
portion to control the position and orientation of the cutting
wire. An expansible balloon is mounted on the distal portion spaced
from the cutting wire and can be inflated through the third lumen
in order to move any gallstone in the biliary tree through the
enlarged sphincter of Oddi.
[0020] In accordance with still another aspect of this invention,
the apparatus is provided for directing contrast agent into the
biliary tree and performing a sphincterotomy through the working
channel of a duodenoscope. This apparatus includes a catheter that
is directed through the working channel of the duodenoscope and the
sphincter of Oddi into the biliary tree. The catheter includes
first, second and third lumens with the first lumen being larger
than either the second or third lumens and the lumens generally
extending between proximal and distal portions of the catheter
along parallel axes. Apparatus for cutting the sphincter of Oddi
includes a cutting wire extending through the second lumen and
externally of the catheter means through a distal port along a
length that is coextensive with part of said distal portion of the
catheter. A handle attaches to the catheter into the proximal wire
portion to control the position and orientation of the cutting
wire. The proximal port of the third lumen connects to a contrast
agent source and the third lumen delivers contrast agent into the
biliary tree through a distal port in the distal end of the
catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The appended claims particularly point out and distinctly
claim the subject matter of this invention. The various objects,
advantages and novel features of this invention will be more fully
apparent from a reading of the following detailed description in
conjunction with the accompanying drawings in which like reference
numerals refer to like parts, and in which:
[0022] FIG. 1 is a plan view of one embodiment of apparatus
constructed in accordance with this invention;
[0023] FIG. 2 is a cross-section taken along lines 2-2 in FIG.
1;
[0024] FIG. 3 is a cross-section taken along lines 3-3 in FIG.
2;
[0025] FIG. 4 is a cross-section taken along lines 4-4 in FIG.
2;
[0026] FIG. 5 depicts the apparatus of FIG. 1 positioned through a
duodenoscope for injecting contrast agent into the biliary
tree.
[0027] FIG. 6 is an enlarged view that depicts the orientation of
the apparatus in FIG. 1 for performing a sphincterotomy;
[0028] FIG. 7 depicts the apparatus of FIG. 1 positioned through a
duodenoscope for dislodging material within the common bile
duct;
[0029] FIG. 8 is a cross-section of an alternative embodiment of
the apparatus as viewed generally along lines 3-3 in FIG. 2.;
and
[0030] FIG. 9 is a cross-section of still another embodiment of
this invention taken along lines 3-3 in FIG. 2.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0031] FIG. 1 depicts a catheter apparatus 10 that has the
capability of injecting a contrast agent into the biliary tree, of
performing a sphincterotomy and of dislodging a gallstone into the
duodenum. The apparatus 10 includes a catheter 11 which, for
purposes of definition, includes a proximal end portion 12
extending from a proximal end 13 and a distal end 14 with a distal
portion 15 extending a short distance from the distal end 14. In a
typical application, the catheter will have a working length of 200
cm and the distal end portion 15 will have a length of 6 cm to 9
cm. Normally the distal portion 15 will have a diameter that is
smaller than the diameter of the proximal portion to increase the
flexibility of the distal portion 15. The reduction in diameter
also makes the tip less traumatic and allows the tip portion to
reach smaller passages while allowing the larger proximal portion
to provide necessary hoop strength and rigidity, particularly where
the proximal portion 13 is coextensive with the working channel of
a duodenoscope. For example, the proximal and distal portions might
have diameters corresponding to 7 Fr and 5.5 Fr catheter sizes
(i.e., 0.09" and 0.07" respectively).
[0032] As shown particularly in FIG. 2, the catheter 11 has three
lumens. A first lumen 16 has a diameter that is greater than either
a second lumen 17 or a third lumen 20. In one particular embodiment
the lumen 16 has a diameter of 0.040" in the proximal portion 13
that reduces to about 0 .037" in the distal portion 15 to receive a
standard 0.035" guidewire. In addition the lumen 16 is offset from
the center of the catheter 11.
[0033] The lumens 17 and 20 are each smaller in diameter than the
lumen 16 and are radially offset from the centerline of the
catheter, from each other and from the lumen 16. In one particular
embodiment the lumens 17 and 20 each have internal diameters of
0.028" in the proximal portions 13 that reduces to about 0.020" in
the distal portion 15. As described later, this lumen 20 carries a
cutting wire for performing a sphincterotomy and for allowing the
infusion of a contrast agent at reasonable rates. The angular
spacing between the lumens 17 and 20 is about 45.degree. and the
angular spacing between the first lumen 16 and each of the lumens
17 and 20 each is about 157.5.degree.. In this configuration and
with these dimensions the proximal portion 13 readily passes
through the working channel of any duodenoscope.
[0034] Referring again to FIGS. 1 and 2, each of the lumens 16, 17
and 20 includes an entry port in the proximal portion 13 and an
exit port in the distal portion 15. Generally, and as described in
more detail later, the first lumen 16 has an exit port through the
distal end 14 while the exit ports for the lumens 17 and 20 can be
sited at different locations in the distal portion 15 depending
upon a particular application.
[0035] In FIG. 1, the entry ports in proximal portion 13 adjacent
the proximal end 12 include an entry port 21 that provides access
to the lumen 16 and includes an optional Leur lock fitting 22. A
proximally positioned entry port 23 provides access to the lumen 17
and includes an optional Leur lock fitting 24. A proximal entry
port 25 for the lumen 20 is located coextensively with a portion of
a handle 26 attached to the proximal end 12.
[0036] Referring to the distal end portion 15, the catheter 11 in
this particular embodiment carries an expansible balloon 30
proximally of the excursion of a cutting wire 31 externally of the
catheter 11. As shown in FIG. 3, the lumen 17 emerges at a distal
exit port 32 through the side of the catheter 11 with the interior
of the expansible balloon 30. An extension of the lumen 17 beyond
the distal port 32 is sealed by known methods of manufacture.
Consequently, fluid forced through the entrance port 23, as by a
syringe (not shown) attached to the Leur lock fitting 24, expands
the balloon 30 into an occluding orientation as shown in FIG. 3
with an inflated diameter in the range up to 20 mm.
[0037] As will also be apparent from viewing FIGS. 3 and 4, the
first lumen 16 extends through the catheter 11 and terminates with
an exit port 33 in the distal end 14. Thus the lumen 16 is adapted
for receiving a guidewire through the entrance port 21 that will
extend through the catheter 11 and exit the distal end 14 and allow
the catheter to slide over that guidewire.
[0038] Referring to FIG. 4, a distal end 34 of the cutting wire 31
attaches to a clamp 35 formed at the distal end of the lumen 20.
Spaced skived ports 36A and 36B allow an active portion 37 of the
cutting wire 31 to emerge from the catheter 11 through the skived
aperture 36A, parallel the catheter 11 exteriorly thereof and
return into the lumen 20 through the port 36B and a reinforcing
sleeve 38. The cutting wire 31 then extends through the lumen 20 to
the handle 26 shown in FIG. 1 where it emerges as a proximal end
portion 40.
[0039] The handle 26, as shown in FIG. 1, includes a central member
41 terminating with a thumb ring 42. The central member 41 extends
through and slides with respect to a body section 43 having opposed
finger rings 44. The central member 41 also attaches to the
catheter 11, and is therefore an extension of the catheter 11. The
member 43 additionally includes an internal connector 45 for
clamping the proximal end 40 of the cutting wire 31. Thus, when the
body 43 is at its distal position as shown in FIG. 1, the distal
portion of the catheter is is in essentially straight line as shown
in FIG. 1 with the active portion 37 of the cutting wire 31 being
closely adjacent the catheter 11. Retracting the body portion 43,
causes the cutting wire 31 to bend the distal end upwardly as shown
in FIG. 1 to a position that is essentially at right angles to the
main axis of the catheter, as will be shown later.
[0040] The connector block 45 and the cutting wire 31 are generally
conductive members that attach through an RF connector 46 to an RF
heating source 47. The use of such RF heating sources 47 for
energizing a cutting wire 31 thereby to cut the sphincter muscle is
well known in the art and represents one possible sphincterotomy
procedure that can be adapted for the apparatus of this invention
and is not described further.
[0041] With this description of the apparatus structure, it will
now be possible to understand its use in a particular application.
FIG. 5 discloses, in a partially broken and schematic view, the
positioning of a duodenoscope 50 in the duodenum 51 adjacent the
sphincter of Oddi 52. A catheter 11 such as constructed in FIG. 1
passes through the sphincter of 0ddi 52 into the common bile duct
53, bypassing the pancreatic duct 54. The distal end 14 does not
extend to the gallbladder 55.
[0042] Fluoroscopy allows the appropriate positioning by utilizing
a series of radio-opaque markers 56 at the distal portion 15 that
may include the clamp 35 and the reinforcing sleeve 38 in. FIG. 4.
The catheter 11 can be positioned with or without the presence of a
guidewire 57 in the lumen 16 shown in FIGS. 2, 3 and 4. For
purposes of injecting the contrast agent, any guidewire 57 can be
withdrawn to allow the contrast agent to be injected through the
lumen 16 for purposes of fluoroscopic examination to confirm the
presence of one or more gallstones 58. It is also possible during
the operation to expand the balloon 30 to occlude the bile duct 53
and block any migration of contrast agent into the duodenum 51 or
the pancreatic duct 54.
[0043] FIG. 6 is an enlarged view showing the duodenum 51,
sphincter of Oddi 52, portions of the pancreatic duct 54 and the
common bile duct 53. In FIG. 6 the catheter 11 has been positioned
relative to the duodenoscope 50 through the opening of the
sphincter of Oddi 52. The handle 43 in FIG. 1 has been drawn
proximally to deflect the distal portion 15 into essentially a
right angle configuration such that the cutting wire 31 abuts
apportion of the sphincter of Oddi 52. The application of RF
heating to the cutting wire 31 then will cut the sphincter of Oddi
52 and enlarge the opening therethrough. As will be apparent, the
sphincterotomy is performed with direct visualization of the
sphincter of Oddi through the duodenoscope.
[0044] Moreover, as has been observed by others, catheters having
guidewire and cutting wire lumens tend to assume a particular
angular orientation when the distal portion 15 emerges from the
duodenoscope. This orientation is essentially independent of the
angular position of the catheter when it is inserted into the
duodenoscope. The offset nature of the lumen 20 as shown in FIG. 2,
improves the location of the cutting wire 31 as the distal portion
15 passes through the sphincter of Oddi 52. Specifically the
angularly offset brings the cutting wire 31 into better alignment
with the common bile duct 53 and displaces the cutting wire from
the pancreatic duct 54.
[0045] FIG. 7 depicts the catheter after the sphincterotomy and
after the catheter 11 is advanced over the guidewire 57, if used.
FIG. 7 also discloses the catheter 11 after the balloon 30 has been
moved beyond a gallstone 58 in the bile duct 53. The balloon 30 is
expanded so that upon withdrawal of the catheter 11 the balloon 30
will dislodge the gallstones 57 and sweep them through the
sphincter of Oddi 52 into the duodenum 51.
[0046] As will now be apparent from the description of the
particular catheter apparatus 10 shown in FIG. 1 and its use as
discussed with respect to FIGS. 5, 6, and 7, the single catheter
apparatus of this invention is capable of providing diagnostic
contrast agent injection, of performing a sphincterotomy and of
dislodging gallstones in the common bile duct or other portions of
the biliary tree without having to exchange a catheter. Moreover,
positioning and sizing of the lumens enables these functions to be
performed with a catheter apparatus that is readily adapted for use
in the working channels of standard duodenoscopes. Consequently the
gallstones can be removed from the biliary tree without bile duct
incisions and accompanying surgical procedures, as duodenoscope can
be introduced through the alimentary tract. Consequently the entire
procedure is adapted for being performed more rapidly than prior
art procedures and with fewer components. The net effect is to
reduce patient trauma and the overall time and cost of conducting
the procedure.
[0047] In FIG. 1 the balloon 30 is located proximally of the
cutting wire 31. FIG. 8 discloses an alternative embodiment in
which a balloon 60 is located distally of the cutting wire 31. More
specifically, the distal end of a lumen 17A, corresponding to the
lumen 17 in FIGS. 3 and 4, is sealed. A side facing exit port 61
skived or otherwise formed in the catheter 11 opens into a chamber
62 formed by the balloon 60. A first sealing portion 63 and a
sealing portion 64 of the balloon 60 connect proximally and
distally of the aperture 61 respectively and seal the chamber
62.
[0048] Introduction of a balloon inflation fluid through the lumen
17A expands the balloon 60 into an occluding orientation
corresponding to the orientation of the balloon 30 shown in FIG. 3.
Retraction of the catheter 11 with the distal balloon 60 inflated
enables withdrawal of a gallstone from the bile duct. This
particular embodiment is particularly adapted when it is determined
that a gallstone is located high in the biliary tree to minimize
the incursion of the distal portion 15 through the biliary tree
beyond the gallstone or in any application in which the internist
desires to minimize the length of the distal portion 15 that
extends beyond the occluding balloon.
[0049] FIG. 9 discloses another embodiment of this invention for
enlarging the sphincter of Oddi and performing another procedure,
such as injecting a contrast agent into the biliary tree, as might
be used in the diagnosis and treatment of a stricture in the
biliary tree. In this particular embodiment an exit port 65 from
the lumen 17B is located in the distal end of the distal portion
15. The lumen 16 then can be used for a guidewire and the lumen
17B, for injecting the contrast agent directly into the biliary
tree while the guidewire remains in place. The apparatus would then
be positioned to perform a sphincterotomy without having to
exchange a catheter should the procedure be warranted.
[0050] As still another alternative, the internist could utilize a
conventional catheter for purposes of injecting the contrast agent
to determine the need for gallstone removal. If treatment were
indicated, the internist could then utilize apparatus as shown in
FIG. 1 with a single exchange over the guidewire that would pass
through the lumen 16 as previously described.
[0051] Therefore, it will now be apparent that apparatus
constructed in accordance with this invention attains the several
objects and the advantages of this invention. More particularly,
catheter apparatus constructed in accordance with this invention
allows the injection of a contrast agent, the performance of a
sphincterotomy and dislodging gallstones from the common bile duct
through the enlarged sphincter of Oddi into the duodenum all
without requiring any catheter exchanges. Moreover, this apparatus
allows such a procedure to occur through a duodenoscope to minimize
patient trauma. The use of a single catheter with an elimination of
catheter exchanges further reduces the time and costs associated
with the use of multiple, single-function catheter devices.
[0052] As will be apparent from the foregoing description, many
alterations can be made to the specifically disclosed embodiments.
Different balloon structures can be used and located at alternative
positions. Different cutting wire embodiments and orientations can
be used. Thus, although this invention has been disclosed in terms
of certain embodiments, it will be apparent that many modifications
can be made to the disclosed apparatus without departing from the
invention. Therefore, it is the intent of the appended claims to
cover all such variations and modifications as come within the true
spirit and scope of this invention.
[0053] What is claimed as new and desired to be secured by Letters
Patent of the United States is:
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